1. Field of the Invention
The present invention relates to an adjustable universal blank which is used to modify the curvature of a live cornea when implanted therein. The blank includes a synthetic or organic material which is adaptable for ablation by a laser beam while the blank is supported on an exposed surface of the cornea, and which further can cause area of the blank to increase or decrease in volume when that area is irradiated with energy such as light of a particular wavelength, microwaves, or thermal energy.
2. Description of the Related Art
A normal emetropic eye includes a cornea, lens and retina. The cornea and lens of a normal eye cooperatively focus light entering the eye from a far point, i.e., infinity, onto the retina. However, an eye can have a disorder known as ametropia, which is the inability of the lens and cornea to focus the far point correctly on the retina. Typical types of ametropia are myopia, hypermetropia or hyperopia, and astigmatism.
A myopic eye has either an axial length that is longer than that of a normal emetropic eye, or a cornea or lens having a refractive power stronger than that of the cornea and lens of an emetropic eye. This stronger refractive power causes the far point to be projected in front of the retina.
Conversely, a hypermetropic or hyperopic eye has an axial length shorter than that of a normal emetropic eye, or a lens or cornea having a refractive power less than that of a lens and cornea of an emetropic eye. This lesser refractive power causes the far point to be focused in back of the retina.
An eye suffering from astigmatism has a defect in the lens or shape of the cornea. Therefore, an astigmatic eye is incapable of sharply focusing images on the retina.
Optical methods are known which involve the placement of lenses in front of the eye, for example, in the form of glasses or contact lenses, to correct vision disorders. A common method of correcting myopia is to place a xe2x80x9cminusxe2x80x9d or concave lens in front of the eye in order to decrease the refractive power of the cornea and lens. In a similar manner, hypermetropic or hyperopic conditions can be corrected to a certain degree by placing a xe2x80x9cplusxe2x80x9d or convex lens in front of the eye to increase the refractive power of the cornea and lens. Lenses having other shapes can be used to correct astigmatism. The concave, convex or other shaped lenses are typically configured in the form of glasses or contact lenses.
Although these optical methods can be used to correct vision in eyes suffering from low myopia up to 6 diopters, or in eyes suffering from hypermetropic, hyperopic or astigmatic conditions which are not very severe, that method is ineffective in correcting vision in eyes suffering from sever forms of ametropia. For example, known optical methods are typically ineffective in correcting high myopia of 6 diopters or greater, and are also ineffective in correcting severe astigmatism and severe forms of hypermetropia or hyperopia.
However, surgical techniques exist for correcting these more severe forms of ametropia to a certain degree. For example, in a technique known as myopic keratomileusis, a microkeratome is used to cut away a portion of the front of the live cornea from the main section of the live cornea. The cut portion of the cornea is frozen and placed in a cryolathe where it is cut and reshaped. Altering the shape of the cut portion of the cornea changes the refractive power of this cut portion, which thus affects the location at which light entering the cut portion of the cornea is focused. The reshaped cut portion of the cornea is then reattached to the main portion of the live cornea. Hence, it is intended that the reshaped cornea will change the position at which the light entering the eye through the cut portion is focused, so that hopefully the light is focused on the retina, thus remedying the ametropic condition.
The myopic keratomileusis technique is known to be effective in curing myopic conditions within a range of 6 to 18 diopters. However, the technique is impractical because it employs very complicated and time consuming freezing, cutting and thawing processes. Furthermore, the technique is ineffective in correcting myopic conditions greater than 18 diopters.
Keratophakia is another known surgical technique for correcting sever ametropic conditions of the eye by altering the shape of the eye""s cornea. In this technique an artificial organic or synthetic lens is implanted inside the cornea to thereby alter the shape of the cornea and thus change its refractive power. Accordingly, as with the myopic keratomileusis technique, it is desirable that the shape of the cornea be altered to a degree allowing light entering the eye to be focused correctly on the retina.
However, the keratophakia technique is impractical, complicated, and expensive because it requires manufacturing or cutting a special lens prior to its insertion into the cornea. Hence, a surgeon is required to either maintain an assortment of many differently shaped lenses, or alternatively, must have access to expensive equipment, such as a cyrolathe, which can be used to cut the lens prior to insertion into the cornea. Examples of known techniques for modifying corneal curvature, such as those discussed above, are described in U.S. Pat. No. 4,994,058 to Raven et al., U.S. Pat. No. 4,718,418 to L""Esperance, U.S. Pat. No. 5,336,261 to Barrett et al., and a publication by Jose I. Barraquer, M.D. entitled xe2x80x9cKeratomileusis and Keratophakia in the Surgical Correction of Aphakiaxe2x80x9d. The entire contents of each of these patents are incorporated herein by reference.
Surgical techniques involving the use of ultraviolet and shorter wavelength lasers to modify the shape of the cornea also are known. For example, excimer lasers, such as those described in U.S. Pat. No. 4,840,175 to Peyman, referenced above, which emit pulsed ultraviolet radiation, can be used to decompose or photoablate tissue in the live cornea so as to reshape the cornea.
Specifically, a laser surgical technique known as laser in situ keratomycosis (LASIK) has been previously developed by the present inventor. In this technique, a portion of the front of a live cornea can be cut away in the form of a flap having a thickness of about 160 microns. This cut portion is removed from the live cornea to expose an inner surface of the cornea. A laser beam is then directed onto the exposed inner surface to ablate a desired amount of the inner surface up to 150-180 microns deep. The cut portion is then reattached over the ablated portion of the cornea and assumes a shape conforming to that of the ablated portion.
However, because only a certain amount of cornea can be ablated without the remaining cornea becoming unstable or experiencing outbulging (eklasia), this technique is not especially effective in correcting very high myopia. That is, a typical live cornea is on average about 500 microns thick. The laser ablation technique requires that at least about 200 microns of the corneal stroma remain after the ablation is completed so that instability and outbulging does not occur. Hence, this procedure typically cannot be effectively used to correct high myopia of greater than 15 diopters because in order to reshape the cornea to the degree necessary to alter its refractive power so as to sufficiently correct the focusing of the eye, too much of the cornea would need to be ablated.
Accordingly, as described in U.S. Pat. No. 5,919,185 cited above, another technique has been developed by the present inventor which involves placing a universally sized blank made of organic or synthetic material on an exposed inner surface of a live cornea, and ablating the blank with a laser beam to alter the blank to a particular shape. Specifically, a flap-like portion of the live cornea is removed to expose an inner surface of the cornea, and the blank is positioned on the exposed inner surface of the eye. A laser beam is directed onto certain portions of the blank that are selected based on the type of ametropic condition (i.e., myopia, hyperopia or astigmatism) of the eye needing correction, so that the laser beam ablates those portions and thus reshapes the blank. The laser beam can also be directed onto certain portions of the laser surface of the cornea to ablate those surfaces of the cornea. The flap-like portion of the cornea is repositioned over the remaining portion of the blank, so that the remaining portion of the blank influences the shape of the reattached flap-like portion of the cornea and thus modifies the curvature of the cornea.
This technique is effective in modifying the curvature of the cornea to correct the types of severe vision disorders described above. However, after the initial procedure has been performed, it is at times necessary to further modify the size and shape of the implanted blank to make fine adjustments to its refractive power, and thus further improve the patient""s vision. In this event, it is necessary to reopen the flap in the cornea, and either further ablate the blank on the exposed corneal surface, or replace the blank with another blank having a size and shape more suitable to correct the vision disorder. This additional surgery can create the risk of damage to the patient""s eye, and cause further patient discomfort.
A need therefore exists for improved methods for further modifying an implanted blank to better correct very severe ametropic conditions.
An object of the present invention is to provide a system and method for adjusting, without ablation, the size and shape of a blank that has been implanted into a live cornea to modify corneal curvature to thus correct severe ametropic conditions.
Another object of the invention is to provide a blank that can be implanted into a live cornea to modify corneal curvature to thus correct severe ametropic conditions, and which is modifiable without ablation.
A further object of the invention is to provide a blank including a material that increases the volume of the blank in response to energy, and which further includes a material that shrinks or decreases the volume of the blank in response to energy, without ablating the blank.
These and other objects are substantially obtained by providing a universally sized blank made of organic material, synthetic material, or a combination of organic and synthetic material, that can be placed on an exposed inner surface of a live cornea and ablated with a laser beam to be altered to a particular shape. The universally sized blank can be porous to allow oxygen and nutrients to pass there through. Also, the blank can be made from living cells such as a donor cornea of a human eye (e.g., as taken from an eye bank), or can be taken from a cultured cornea. The blank can further include material which increases the volume of the blank in response to energy, and another material that shrinks or decreases the volume of the blank in response to energy.
A flap-like portion of the live cornea is removed to expose the inner surface of the cornea. The blank is positioned on the exposed inner surface of the cornea and, if desired, a laser beam is directed onto certain portions of the blank to ablate those portions and thus reshape the blank based on the type of ametropic condition (i.e., myopia, hyperopia or astigmatism) of the eye needing correction. The flap-like portion of the cornea is then repositioned over the remaining portion of the blank, so that the remaining portion of the blank influences the shape of the reattached flap-like portion of the cornea, thus modifying the curvature of the surface of the cornea. Whether or not the blank has been ablated, the appropriate energy can be applied to the blank, to increase or decrease the volume of the blank, as desired, to further alter the curvature of the cornea to more precisely correct the vision disorder.
Alternatively, the blank include multiple sections. Certain of these sections can be removed or added, as appropriate, to modify the curvature of the surface of the cornea by the necessary amount to correct the vision disorder.